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Activate/Inactivate SAE form field

In the EDC application, the maintenance of the serious adverse event (SAE) forms occurs under the STUDY INFO > SAE Form Define subtab. Here you can add fields to the form as well as temporarily activate or inactivate them.

For instance, the option can be helpful if you want to hide the field from the SAE form but you know that you will need to reintroduce it later on. Thus, you do not need to delete it and then add it again from scratch. You can simply inactivate and then activate the field.

To activate or inactivate the SAE form field

  1. In the EDC application header, select the STUDY INFO tab.

  2. On the page that opens, in the left pane, select SAE > SAE Form Define.

  3. In the SAE Form Define table that appears, locate the field of your interest and in the Actions column next to it, select one of the following options:

    • Activate activate_icon.png: to make the field active and available for data entry in the SAE form.

    • Inactivate inactivate_icon.png: to make the field inactive and hide it from the SAE form.

Upon selecting, the SAE form field is activated or inactivated based on the performed action. You can also delete fields from the SAE form.

In this section:

An adverse event that results in death, is life-threatening, requires subject hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.